Kornimate/medical-research-clean huggingface dataset:
long-term safety and tolerability of iptacopan in patients with paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with pnh who have completed novartis-sponsored phase 2 or 3 studies with iptacopan

the purpose of this phase 3 open-label, single arm, multicenter study is to evaluate the long-term safety, tolerability and efficacy of iptacopan in patients with pnh and to provide access to patients who have completed (without tapering down) phase 2 and phase 3 trials and derived benefit from iptacopan treatment.

Eligibility criteria:
inclusion criteria: * male and female participants ≥ 18 years of age with a diagnosis of pnh who have completed the treatment extension period (without tapering down) of phase ii iptacopan studies (clnp023x2204, clnp023x2201), period 4 of lfg316x2201 or phase iii (clnp023c12302 and clnp023c12301) clinical studies at the time point of enrollment visit in this roll over extension. * prior vaccinations against neisseria meningitidis, streptococcus pneumoniae and haemophilus influenzae infections * per investigator's clinical judgement benefit from continued treatment with iptacopan and has been clinically stable on iptacopan monotherapy for at least 3 months exclusion criteria: * any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the investigator, could put the subject at increased risk or potentially confound study data. * history of recurrent invasive infections caused by encapsulated organisms, such as neisseria meningitidis, streptococcus pneumoniae or haemophilus influenzae * history of hematopoietic stem cell transplantation other protocol-defined inclusion/exclusion criteria may apply.

Keywords: iptacopan paroxysmal nocturnal hemoglobinuria (pnh) hemoglobin anemia lnp023
fibromyalgia therapeutic education in thermal cure

Conditions: Fibromyalgia

Summary: the study evaluates the efficiency, in terms of quality of life improvement, of a patient's therapeutic education program (etp), based on long term commitment in adapted physical activities carried out during a standardized thermal cure (cts) for fibromyalgia among patients continuing regular drug treatment or not

fibromyalgia is a poorly known and understood disease. patients suffer from pain, fatigue, sleep disorders, anxiety, depression, preventing them from moving and going out, resulting in an alteration of social life. multiple drugs treatment is frequently used but is burdensome and poorly effective. however, thermal cure proved efficacious to improve quality of life during the cure and beyond. this study aims at demonstrating the added value of a patient's therapeutic education program provided during a thermal cure, a moment where patients are available and receptive to guidance.

Eligibility criteria:
inclusion criteria * diagnostic of fibromyalgia done at least 6 months before thermal cure * diagnostic of fibromyalgia confirmed by first questionnaire (score 5) during the initial thermal checkup * age between 18 and 65 years * access to an internet connection during remote follow-up * affiliation to a social security system (recipient or assignee) * signed written inform consent form exclusion criteria * infectious diseases with ongoing treatment (except for winter upper respiratory tract pathologies) * active tumorous pathology * concomitant inflammatory rheumatism * stage iii chronic venous insufficiency with history of phlebitis and/or pulmonary embolism * incapacity to receive treatment in hot water ( ≥36°) * total incapacity to practice physical activities of therapeutic education program * ongoing pregnancy * involvement in a structured educational program specific to fibromyalgia during the previous year * incapacity to understand french language making the follow up impossible
clinico-immunological characterization and immune tolerance breakdown in cv2-autoimmunity

Conditions: CV2 Autoimmunity

Summary: paraneoplastic neurological syndromes are rare syndromes caused by the remote effects of cancer. they have an immune-mediated pathogenesis, yet the underlying mechanisms are not fully elucidated. cv2/collapsin response-mediator protein 5 (crmp5)-igg paraneoplastic neurological syndrome is characterized by heterogeneous clinical presentations, affecting both central and peripheral nervous system, and the most frequently associate tumor is small cell lung carcinoma. central nervous system involvement along with csf and neuroimaging findings have not been fully described in the literature in cv2/crmp5 patients. unraveling the complexities of cv2/crmp5 paraneoplastic neurological syndrome is critical to improve diagnosis, treatment, and patients' care. our intention is to perform a comprehensive analysis of the clinical characteristics and instrumental investigations of a large cohort of cv2/crmp5 patients.


Eligibility criteria:
inclusion criteria: * patient with paraneoplastic neurological syndromes * patient with cv2 antibody in sera and/or csf exclusion criteria: * patient with no data * patient without neurological disorder * patient without cv2 antibody in sera/csf

Keywords: paraneoplastic neurological disorders, lung cancer, cv2 autoimmunity, immune tolerance breakdown
evaluation of the translation of the de-plan program for the primary prevention of type 2 diabetes in routine primary care

Conditions: Prediabetic State

Summary: the purpose of this study is to evaluate the feasibility and effectiveness of the de-plan euskadi program for the primary prevention of type-ii diabetes in high-risk population seen in primary care centers (osakidetza-basque health service) in which such intervention is implemented, compared to usual care control centers.

objective: to evaluate the feasibility and effectiveness of the de-planє program for the primary prevention of type-ii diabetes in high-risk population seen in primary care centers (osakidetza) in which such intervention is implemented, compared to usual care control centers. design and methods: a phase iv cluster randomized prospective clinical trial, conducted in 14 primary care centers from osakidetza, which will be randomly assigned to intervention or control group, that will collect a sample of 2534 followed for two years, aged 45 to 70 years without diabetes but with high risk of developing it (findrisc scale\> 14), identified by a screening system. nurses in intervention centers (gi) will implement deplanє for 12 months, a structured educational intervention on healthy lifestyles (diet and physical activity), while patients of the control centers will receive standard care for the prevention and treatment of type-ii diabetes. analysis: the feasibility will be reported as the reach, adoption and implementation of the program. the attributable effectiveness of the program will be determined by comparing the changes in the incidence and risk of developing diabetes in healthy habits quality of life, observed in patients exposed to de-planє intervention and of patients from control centers. the incremental cost-utility of de-planє program will be also analysed.

Eligibility criteria:
inclusion criteria: * 45 to 70 years old * high risk of developing type-ii diabetes (findrisc scale \> 14 points) exclusion criteria: * disorders of the cardiovascular system * transplant recipients * renal or hepatic failure * severe chronic obstructive pulmonary disease * severe mental disorders * chronic and acute severe infections * metabolic uncontrolled disorders * restrictive pathology of muscles, bones and joints * complicated pregnancy * contact difficulties

Keywords: lifestyle prediabetic state patient education primary health care
a study evaluating the absorption of dimebon into the body from a dimebon solution applied to the skin

Conditions: Alzheimer's Disease; Huntington's Disease

Summary: to estimate the absorption, safety, and tolerability of a dimebon transdermal solution relative to the dimebon immediate release oral formulation.


Eligibility criteria:
inclusion criteria: * caucasian, male or females, 50 to 85 years inclusive. * subjects must have adequate space available on each side of the upper or middle back that is free from excessive hair, broken or irritated skin, tattoos, scars, moles, acne, and sunburn. exclusion criteria: * evidence or history of any major medical or psychiatric illness or unstable medical condition within six months of screening that may increase the risk associated with study participation. * subjects with any central nervous system disease including alzheimer's disease, parkinson's disease, huntington disease, or any form of dementia. * subjects with any history of stroke, known cerebrovascular disease or subjects with any history of structural brain disease. * any history of epilepsy, seizure disorder (i.e., including febrile seizures) or convulsion. * subjects with any skin disorders that might prevent application of the dimebon solution including, but not limited to, any known sensitivity to adhesives.

Keywords: percutaneous transcutaneous dimebon transdermal pharmacokinetics
biomarkers for identification of covid-19 infection

Conditions: Coronavirus

Summary: acute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (covid-19) also named as sars-cov-2, a new virus emerged in december 2019 in wuhan (china). the diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test, including molecular and/or antigen swab, for diagnosis of positivity to covid-19. even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. the aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in covid-19 infected patients.


Eligibility criteria:
inclusion criteria: * aged between 18 and 75 years, extremes included, male or female in conscious patients, ability to understand and the willingness to sign a written informed consent document; in unconscious patients informed consent will be signed from parents or legal tutors. exclusion criteria: * patients that don't sign the informed consent
antiviral efficacy of the combination treatment with poly ic and entecavir for chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to investigate antiviral efficacy of the combination treatment with poly ic and entecavir and compare with the efficacy of entecavir mono-therapy for chronic hepatitis b.

in this study, the patients with chronic hbv infection will be divided into two groups: hbeag (+) and hbeag (-) group. each group will be divided into two subgroups, which are treated with combination treatment of entecavir and poly ic and entecavir monotherapy respectively. all the patients will be followed up for one year. from this study, the investigators want to study if poly ic can enhance antiviral efficacy of entecavir for chronic hepatitis b.

Eligibility criteria:
inclusion criteria: * hbsag positive for more than 6 months. * having been treated wit entecavir and the level of hbv dna is under 1000 copies/ml. * alt ≤10×uln， tb \<2uln . exclusion criteria: * previous antiviral treatment for hbv. * co infection of hiv, hcv, hev, hav, or hav. * evidence of hepatic carcinoma. * evidence of autoimmune disease. * evidence of thyroid disease. * history of mental sickness.
leveraging ctdna analysis to improve early detection of cancer recurrence in the high-risk melanoma setting

Conditions: Stage III Melanoma; Stage IV Cutaneous Melanoma

Summary: to generate meaningful data regarding ctdna that would infer risk of recurrence in stage iii melanoma patients.

cancer cells harbor and can acquire potentially hundreds of mutations, many of whom are found in the ctdna. circulating tumor dna (ctdna) holds the promise for the 50% of participants who do not need adjuvant therapies - participants could be monitored to ensure no increase in ctdna. participants treated could then be followed for the earliest possible blood level signs of recurrence (incr. ctdna) and more quickly be switched to more effective therapies. further, the treating physician could hold therapy until the first signs of ctdna based recurrence for those participants that would benefit. blood sample from a biobank will be used to identify to monitor ctdna. these blood samples were drawn at baseline, 3 months, 6 months and 18 months.

Eligibility criteria:
inclusion criteria: * age ≥18 * confirmed fully resected stage iiib-iv cutaneous melanoma; including patients treated neoadjuvantly within three months prior to resection. exclusion criteria: • treatment plan inconsistent with the standard of care systemic adjuvant therapies 4.0 study design
endocrine, metabolic and inflammatory characteristics of offspring of mothers with pcos hyperandrogenism

Conditions: PCOS

Summary: this study is a cross-sectional study to explore the endocrine metabolism and inflammatory characteristics of the offspring of mothers with pcos hyperandrogenism, in order to provide a theoretical basis for finding the cause of pcos.

this study randomly selected 20 women with pcos and hyperandrogenism who gave birth to a singleton at term at guangdong maternal and child health hospital from may 2023 to march 2024, and set them as the ha group. in addition, 22 healthy women were randomly selected as controls. group, the fasting blood glucose (fpg) level of the newborn\&#39;s peripheral blood and the androgen, fasting insulin and inflammatory factor levels of the newborn\&#39;s umbilical cord blood were collected respectively. among them, the detection indicators of newborn umbilical cord blood include testosterone (t), androstenedione (and), dehydroepiandrosterone sulfate (dhea-s), sex hormone binding globulin (shbg), free androgen index (fai), fasting insulin (fins), white blood cell count (wbc), neutrophil count (neut), high-sensitivity c-reactive protein (hs-crp), and interleukin (il)-6. all collected data were statistically analyzed to compare the differences in levels of androgens, fasting insulin, and inflammatory factors in the umbilical cord blood of newborns in the ha group and the control group.

Eligibility criteria:
inclusion criteria: * the diagnosis of polycystic ovary syndrome patients must meet the rotterdam criteria. * aged between 18 and 45 years old. * the gestational age of delivery is between 37 and 41 weeks of gestation. * hyperandrogenemia inclusion criteria: elevated peripheral blood androgens, including testosterone, androstenedione, and dehydroepiandrosterone sulfate. * singleton pregnancy. * signed informed consent form. exclusion criteria: * combined with reproductive organ malformations or chromosomal abnormalities. * combined with chronic diseases such as diabetes and hypertension. * combined with thyroid disease or other serious systemic diseases such as cardiovascular disease. * multiple pregnancy. * combined with congenital adrenal hyperplasia, cushing\&#39;s syndrome, hypertension prolactinoma, and androgen-secreting tumor-related diseases.

Keywords: pcos hyperandrogenemia offspring endocrine and metabolism inflammation
coaching of diabetic patients after hospital discharge

Conditions: Type 2 Diabetes

Summary: one third of the costs of medical care for people with diabetes are related to hospitalization." difficult" diabetic patient, i.e. those with very high hba1c, patients \> 75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high rate of readmission when discharged at home after an initial hospitalization related to diabetes or its complications. the objective of the study is to test if a coaching with a care coordinating team after hospital discharge would decrease diabetes-related rehospitalization rate compared with usual care.

patients with type 1 (t1d) or type 2 diabetes (t2d) hospitalized (\>24h) and presenting at least a risk factor for readmission after discharge at home, will be randomized, at time of discharge, between 2 groups: an "intervention" group and a control group (usual management). intervention will consist in optimized organization of discharge at home followed by a ambulatory individualized coaching by a nurse including an initial situation assessment, a consultation meeting with the patient's gp in order to propose a health personalized plan, then a follow up program with a face to face session each trimester in order to remind the objectives, to assess compliance to the plan, to evaluate difficulties encountered and to help to find solutions. final data collection will be done in both groups by questioning the patient's general practitioner (gp) and by collecting data on potential hospitalization. expected duration : 3 years. readmission rate, duration and causes of hospitalization will be compared between both groups. impact of the results : reduction of costs, improved use of hospital specialized resources.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes and at least one of the following criteria: * admission for more than 5 days * unplanned admission * at least one urgent care/emergency room visit in the 6 previous months, whatever its cause * hba1c \> 10% on admission * cardiovascular event in the previous year : cardiac failure, myocardial infarction, coronary or peripheral revascularization procedure, stage iv peripheral arteriopathy, stroke. * occurence during the previous year of a foot lesion requiring an admission or lasting more than one month (foot lesion risk stage 3) exclusion criteria: * patients with one of the following co-morbidity: cancer in active phase of treatment, parkinson's disease treated, severe chronic respiratory failure, * refusal of signing the consent, * patients non affiliated to social security, * pregnant women, * people who do not understand french (except if accompanied by somebody able to translate), * renal dialysis, * patients aged less than 18 years, * patients already in a similar type of trial * the arisen of a pregnancy or a cancer will cause the stop of the study

Keywords: coaching therapeutic education hospital admission quality improvement strategies management program nurse follow up discharge planning rehospitalization
nicotinic agonist effects on bmi and neuronal response

Conditions: Obesity

Summary: obesity is a serious and growing health problem in the united states. obesity is associated with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased quality of life and increased mortality. given the health and quality-of-life effects of obesity, developing effective treatments clearly is an important goal. this study plans to learn more about the effects of an investigational new drug (dmxb-a (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. the study drug has similar effects to nicotine. since nicotine has been found to affect appetite, the investigators are interested in studying effects of the study drug, which has some similarities to nicotine, on how your brain responds to such things as pictures of food. the study drug has not been approved by the food and drug administration (fda), and is considered experimental.


Eligibility criteria:
inclusion criteria: * overweight/obese (bmi \> 27) * between 21-65 years old exclusion criteria: * known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension * women capable of conception (must be post-menopausal, surgically sterilized, or have adhered to an anti-contraception birth control regimen for at least 1 year) * nicotine use * significant endocrine/metabolic disease * kidney disease * neurological illness * liver disease * medication use affecting appetite and/or metabolism * mri-specific exclusion criteria (e.g., claustrophobia, metal in the body)
retrobulbar injection of anesthesia versus healon 5 in the management of intraoperative floppy iris syndrome

Conditions: Intraoperative Floppy Iris Syndrome

Summary: in this study, the investigators plan to compare the incidence and complications of intraoperative floppy iris syndrome (ifis) during cataract surgery in patients taking tamsulosin (flomax) and treated with retrobulbar injection of anesthesia, versus injection of healon 5 viscoelastic into the anterior chamber.


Eligibility criteria:
inclusion criteria: * all cataract patients taking tamsulosin exclusion criteria: * patients with any history of iridocyclitis * presence of iris neovascularization * history of prior iris surgery * presence of traumatic cataracts * presence of zonular dialysis

Keywords: floppy iris syndrome
a study comparing mircera and epoetin alfa for the treatment of anemia in dialysis patients with chronic kidney disease.

Conditions: Anemia

Summary: this 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (hb) levels, of methoxy polyethylene glycol-epoetin beta (mircera) and epoetin alfa, in anemic patients with chronic kidney disease (ckd) on hemodialysis. patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive mircera 120-360 micrograms (iv), monthly. after a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * ckd (stage v) on outpatient hemodialysis therapy for \>= 3 months; * ckd-related anemia treated with epoetin alfa iv 3x/week for \>= 3 months; * average hemoglobin (hb) 10-12 g/dl over last 3 months. exclusion criteria: * failed renal transplant within 12 months prior to screening; * poorly controlled hypertension; * previous treatment with mircera.